-
BCG shortage?!
Has anyone else heard this? My treatments are being postponed from August to October…any input appreciated!
-
33 Replies
-
Merck had a problem in their production of BCG earlier in the year shutting down production until they corrected the problem under The FDA guidelines. As they are the major producers of BCG in the world at this point this has caused problems and major worry for non invasive bladder cancer survivors.
Merck has began production and shipment has resumed. They will be filling back orders and it will take a while for production to return to baseline and the pipeline to be back to normal.
The above is the best answer available at this time and comes from Merck. The truth is that BCG is only one of hundreds of drugs that are in a state of shortage at any given time in the US. This is due to many factors, manufacturing glitches as well as economic reasons.
We have seen shortages in the past this is not the first nor potentially the last. BCG is a biological and because of this the manufacturing of it can be impacted by many factors. Also it is an old drug no longer under patent and demanding the wildly high prices of new drugs on the market. Even without speculating on other factors it answers the questions of why more company’s are not manufacturing it and why do we see shortages?
On a personal note I hear the reasons and understand them but can not help thinking that the FDA would be in panicked problem solving mode if the drug in question was Viagra. Can you imagine the press that would get? Call me cynical.
The bottom line is this, if you feel your treatment is being compromised by the BCG shortage it is time to talk to your Urologist about alternatives. If your Urologist is not converse in what is available seek a second opinion from one that specializes in bladder cancer at a major cancer center.
Cynthia Kinsella
T2 g3 CIS 8/04
Clinical Trial
Chemotherapy & Radiation 10/04-12/04
Chemotherapy 3/05-5/05
BCG 9/05-1-06
RC w/umbilical Indiana pouch 5/06
Left Nephrectomy 1/09
President American Bladder Cancer Society
There have been two sources of supply of BCG in the US…Thercys (which is the one I had) is now not on the market. Merck also has one and, according to the FDA Bureau of Biologics web site, it is back on the market. BUT you would need to ask your urologist ….maybe for some reason he doesn’t use the Merck version.
But if and when you have questions such as this, do ask your doctor. He can give you the specific reasons for his reply
Sara Anne
Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator
“Accurate”? You’re joking right? Do you not understand my query…Sarah…plz may I have you thoughts reguarding why an oncologist/urologist from one of the country’s top hospitals would tell me this…if it werent true?!!
Gina, sorry for your state of confusion. At least now you have accurate information to help calm the worries.. God bless you!!!
I am terribly confused and discouraged…I am not crazy…my urologist/onocologist from the University of Michigan told me what I stated above…days ago…why would he say this if it werent true?…. I asked him further, what does this mean for me and my treatment?…His response, “you and every other bladder cancer patient”….thoughts?
BCG is a live product, and so is regulated in the FDA by the vaccines, blood and biologics division. Here is the link
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm
According to this listing, Theracys is NOT available, but version supplied by Merck is.
Sara Anne
Diagnosis 2-08 Small papillary TCC; CIS
BCG; BCG maintenance
Vice-President, American Bladder Cancer Society
Forum Moderator
Gina,
here is the gov fda web site:
http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm#BGod bless you!!!
Gina,
Thank you for your input on this very important subject. Hope your cystoscopy was clear. Did you have your BCG treatment? We checked with our pharmacy Walgreens a couple of weeks ago and they checked availablity and said no problem getting BCG. Also checked with gov web site and there wasn’t an indication of no availablity or shortage.
Had my cystoscopy today…after missing two months of BCG…my doctor said the manufacturer may have stopped making BCG and that it is an international issue, not just in the U.S….every 3 months we’ll continue to watch… ;/
First i apologize for being such a negative nancy…I just received word that all 3 of my maintenance treatments in october have been cancelled…two months out…comments? Needless to say I am worried as these came after my reoccurence
Well..everyone’s information concerning ‘why’ there is a shortage is much appreciated…however my question was asked with hopes of others in my shoes and what thoughts they are having in this regard! My September maintenance round was rescheduled for October… While this worried me somewhat, I was assured that my uro Oncologist knew and approved…nothing to worry about. Last week I received a letter signed by ALL uro oncologists that if the BCG is not received by late October…support teams would need to gather to talk about other options…this from the U of M cancer center, the letter was obviously sent out to many patients…any thoughts? What other options are there? Anyone know?!
My husband had received his 3rd BCG treatment when we were informed about the shortage. They had 2 more doses that they had put back for him but said that with the shortage he wouldn’t receive his 6th treatment. Well we got a call last week and they had received a shipment of the BCG so he will get all 6 treatments. There is hope out there that the shortage is coming to an end and everyone that needs it can get back on track and fight against this…
Just went in for what was supposed to be my 3rd mitomycin treatment – I was to get six of these treatments in place of the remaining two of the six scheduled BCG treatments that were halted after four of them due to the shortage. Good news upon arrival at urology office, they had received four BCG doses that had been on back-order. They allocated 2 of them for me, and I received my 5th dose and will get the final dose (of this round, at least) next week. So, it’s been 9 straight weeks of treatment following the 2 TURB’s. It has certainly been painful, uncomfortable and stressful. Despite it all, I am very grateful for my care and thankful that this type of therapy is available and has proven so successful in keeping the cancer from returning. I was diagnosed with stage one papillary carcinoma of the bladder this past June. They have scheduled a follow up cystoscopy for mid-December. For now, and a day at a time, I remain cancer-free unless someone tells me differently.
Hi Group!!
I just check with my uro and they said no BCG shortage problem!! That is here in Florida. I’am coming up on 24 months…all clean so far…thank you God!!!!and thank you God for my uro and staff!!!!and for BCG treatments!! and for this board…
JW
Hi All, If my memory serves me well,(and it often doesn·t) previous shortages arose when the main US supplier had to make modifications to their production plant to reduce or eliminate risks of contamination into the environment, this disrupted production for some time. As patients, we are told to put bleach into the toilet after bcg treatment – this is not only to prevent risk to our families or work colleagues, but also to destroy any organisms that could find their way into sewage systems for example.At the same time as there were shortages in the US, there seemed to be a shortage world wide.At the moment my urologist(private) does not seem to have any problem in obtaining the medication here in Spain.
Sign In to reply.
